KingPo Delivers Asia’s First Turn-Key IEC 60601-2-2:2017 Full-Scope Laboratory for High-Frequency Surgical Equipment
2025-07-12
KingPo Delivers Asia’s First Turn-Key IEC 60601-2-2:2017 Full-Scope Laboratory for High-Frequency Surgical Equipment
Shanghai, China – July 12, 2025 – KingPo, a global leader in medical electrical safety and performance solutions, today announced the successful commissioning of a turnkey laboratory for high-frequency surgical equipment and accessories that fully complies with IEC 60601-2-2:2017 (including Amendment 1:2023). Located in Zhangjiang Science City, Pudong, Shanghai, the facility is the first in Asia capable of testing every clause of the standard and is immediately ready to support CE, NMPA, and FDA 510(k) registrations for 300 W-class electrosurgical generators, monopolar/bipolar accessories, and disposable neutral electrodes.
Project Highlights • One-stop turnkey delivery: design, construction, equipment procurement, system validation, and dual CNAS & CBTL accreditation coaching—all completed within 180 days. • Full standard coverage: 180+ technical requirements including Clause 201.8 (electrical safety), 201.11 (excessive temperature), 201.17 (EMC), 202 (electromagnetic compatibility), and 208 (alarm systems). • Intelligent platform: embedded KingPo MedLIMS™ automatically captures test data and generates reports, cutting manual data entry by 60 %. • Future-proof: 50 % power headroom built in for seamless upgrade to the upcoming 2026 draft standard.
“KingPo delivered more than a laboratory—they delivered a passport to the global high-frequency surgery market,” said the customer’s CTO at the hand-over ceremony.
KingPo Delivers Asia’s First Turn-Key IEC 60601-2-2:2017 Full-Scope Laboratory for High-Frequency Surgical Equipment
2025-07-12
KingPo Delivers Asia’s First Turn-Key IEC 60601-2-2:2017 Full-Scope Laboratory for High-Frequency Surgical Equipment
Shanghai, China – July 12, 2025 – KingPo, a global leader in medical electrical safety and performance solutions, today announced the successful commissioning of a turnkey laboratory for high-frequency surgical equipment and accessories that fully complies with IEC 60601-2-2:2017 (including Amendment 1:2023). Located in Zhangjiang Science City, Pudong, Shanghai, the facility is the first in Asia capable of testing every clause of the standard and is immediately ready to support CE, NMPA, and FDA 510(k) registrations for 300 W-class electrosurgical generators, monopolar/bipolar accessories, and disposable neutral electrodes.
Project Highlights • One-stop turnkey delivery: design, construction, equipment procurement, system validation, and dual CNAS & CBTL accreditation coaching—all completed within 180 days. • Full standard coverage: 180+ technical requirements including Clause 201.8 (electrical safety), 201.11 (excessive temperature), 201.17 (EMC), 202 (electromagnetic compatibility), and 208 (alarm systems). • Intelligent platform: embedded KingPo MedLIMS™ automatically captures test data and generates reports, cutting manual data entry by 60 %. • Future-proof: 50 % power headroom built in for seamless upgrade to the upcoming 2026 draft standard.
“KingPo delivered more than a laboratory—they delivered a passport to the global high-frequency surgery market,” said the customer’s CTO at the hand-over ceremony.
